Quality Assurance Manager

PRASHANT MENGSHETTI

**** ******** **. **

Apartment E, Atlanta, GA

30329

Cell: 404-***-**** - Home: (404)-314-

**** - ************@*****.***

Summary

Accomplished, results-oriented Pharmaceutical/Quality Professional, with

extensive industry experience, in the areas of Quality Assurance,

Manufacturing, Contract Manufacturing Operations, Technology Transfer,

Operations Training.

Demonstrated and recognized reputation as an energetic, motivated, creative

self- starter with strong leadership skills and ability to build, develop,

and lead superior work and technical teams focused on excellence. Possess

excellent technical, observation, investigative, and interpersonal skills.

Core Competencies

cGMP Self Inspection/Internal Manufacturing Operation

Audits

Quality Management APQR Technology Transfer

System

Document Control Change Control Process Validation

Master Batch Records Deviation Operation Excellence

SOP's Market Complaint Technical/Operations

Training

Batch Release Manufacturing CMO Audits

Investigation/CAPA

Key Deliverables

Quality Assurance

. Devising and implementing company quality assurance program in

compliance with cGMP requirements.

. Prioritizing quality assurance responsibilities based on the

integration of new designs and products in to current production

schedule.

. Attending customer complaints /rejections & corrective actions and

fulfilling customers' requirement.

. Effective QA document control function, including document login,

tracking, processing, approval, distributing, and archiving.

Vendor Management

. Leading supplier selection, assessment and ongoing monitoring

initiatives.

. Ensuring the supplier base consistently achieves the company's

delivery and quality requirements.

. Providing sample approval clearance for vendor components; dealing

with the charge of sample approval clearance for vendor components.

Team Management

. Supervising, managing and supporting the quality assurance personnel

(27 Persons were worked under my guidance)

. Providing administrative and technical direction to all quality

assurance personnel encompassing personnel administration, resolution

of technical problems, development/approval of in-house training.

. Played Key role in global cGMP compliance and successfully faced

audits: WHO-Geneva, UK-MHRA, US-FDA, ANVISA, TGA-Australia, MCC-South

Africa, NDA Uganda and various other countries like Ukraine, Germany

etc.

Experience

Asst. Manager-Corporate Quality Assurance

October 2012 to February 2014 Alembic Pharmaceuticals Ltd - Mumbai,

Maharashtra

Established in 1907, Alembic Pharmaceuticals is Asia's most respected and

integrated company, committed to improving the quality of life and

Healthcare in over 75 countries in the world. Manufacturing facilities are

approved by leading regulatory authorities including the US-FDA, MHRA, TGA,

MCC, ANVISA etc. (http://www.alembic-india.com)

As Assistant Manager-Corporate Quality Assurance, implemented and

maintained Quality Management System in Contract Manufacturing

Organizations (13 Sites) with the current regulatory requirements & Alembic

Quality policy.

. Provided support to the 13 Contract Manufacturing Organizations and

ensured that, there were no product recalls and no batch rejection and

reworks due to quality reason.

. Performed the Contract Manufacturing Site Audits and follow up

compliance audits as per audit matrix

. Carried out review of batch manufacturing records and final batch

release to the Market.

. Looked after the Market Complaint investigation, CAPA, OOS, change

controls and deviations.

. Having Exposure of Technology Transfer Documents with respect to BMR,

BPR, Process Validation Reports, Stability Records, STP,

Specification, Cleaning Validation, etc.

. Imparted training based on need identified for the site / requested by

the site

Manager- Quality Assurance April 2012 to

October 2012 Intas Pharmaceuticals Ltd - Ahmadabad, Gujarat

Intas is a leading vertically integrated global pharmaceutical formulation

development, manufacturing and marketing company headquartered in

Ahmadabad, India. Manufacturing facilities approved by leading drug

regulatory authorities including the USFDA, MHRA, TGA, MCC, ANVISA, GCC

(http://www.intaspharma.com)

As Manager - Quality Assurance for Solid Orals (Manufacturing and

Packaging)

. Looked all shop floor activities pertaining to IPQA activities and

related to cGMP compliance (Tablets & Capsules) and ensured adherence

to quality/regulatory compliances.

. Effectively developed various Quality Assurance SOP's.

. Approved Master documents like Formulation Order and Manufacturing

Instructions.

. Carried out final batch release to the Market.

. Audit preparation and audit compliances.

. Functioned as a Team member for self inspection.

. Looked after the Market Complaint investigation, CAPA, OOS, change

controls and deviations.

. Imparted Training on periodic updates on SOP's and unplanned

deviations.

Manager- Quality Assurance

December 2010 to March 2012

May & Baker Nigeria Plc - Ikeja, Lagos

May & Baker Nigeria Plc is one of the largest public limited company

founded on Sept 4, 1944 as Nigeria is the first Pharmaceutical Company and

number one drug prescription. (http://www.may-baker.com)

As Manager - Quality Assurance for Solid Orals (Manufacturing and

Packaging)

. Initiated activities for establishing May & Baker Nig. Plc Ota Unit

for Pharma Production (Tablets, Capsules) and ensured adherence to

quality compliances.

. Effectively developed various documentations such as: SMF, VMP, market

complaints & Internal Audit Report.

. Having Exposure of TTD with respect to BMR, BPR, Process validation,

Stability Records, Cleaning Validation etc.

. Looked after the entire gamut of operations encompassing CAPA, OOS,

change controls and deviations.

. Approved Master documents like Formulation Order, Manufacturing

Instructions, Packaging Order and Packaging Instructions etc.

. Effective Document Control and issuance of BMR, BPR, SOPS,

Specifications, STPs, Daily formats, Stability Protocol, Validation

Protocol and retrieval and reconciliation.

. Carried out final batch release to the Market.

. Functioned as a Validation Coordinator for Process validation like

prospective, concurrent and re-validation as per market requirements.

. Having exposure of APQR for OSD facilities.

. Effectively Maintained in-house training programs including training

matrix and training files.

Team Leader-Development Quality Assurance December 2007

to November 2010 Laboratories Genpharma - El Jadida, Morocco

Genpharma is a leading manufacturer of generic pharmaceutical products in

Morocco. (http://www.genpharma.ma)

As Team Leader-Development Quality Assurance

. Independently handled Quality Assurance functions in submission of

product dossier of new development product & renewal product to

Ministry of Health Morocco

. Carried out reviewing Pharmaceutical batch records and technical

packages.

. Carried out Preparation and Execution of Process validation Protocol &

Report of Tablets and Capsules.

. Effectively carried out QA Documents Preparations, Review & Approval

such as SOP's, Master BMR & BPR

. Closing of BMR & BPR of exhibit batches for EU & MOH, Morocco

. Carried out reviewing of Product Dossier Check list Documents (BMRs,

BPRs, Process Validation, Cleaning Validation Report, Stability

Report, Hold Time Study Reports etc.) Prior to submit to regulatory

department.

. Verified the core quality system related to New Development products &

Renewal products such as Change control, Deviations, Batch Record,

Process validation & Critical process Monitoring

. Interacted with Quality Head and R&D for resolving product problems.

Sr.Executive-Manufacturing November 2005 to

November 2007

Dr.Reddy's Laboratories Ltd - Hyderabad, Andhra Pradesh

Dr.Reddy's is a leading global generic pharmaceutical company.

Manufacturing facilities approved by leading drug regulatory authorities

including the US-FDA, UK-MHRA,MCC, ANVISA and TGA (http://www.drreddys.com)

As Sr.Executive- Solid Orals Manufacturing

. Independently looked after one entire Tablet Manufacturing Module

. Supervised Day-to-Day activities related to the Tablet manufacturing &

documentation as per cGMP.

. Effectively did the Monthly, Weekly & Daily Manpower and Production

planning.

. Carried out In-process control checks in order to monitor and if

necessary to adjust the process and/or to ensure that the intermediate

or finished product conforms to its specification.

. Handled various Site Transfer products activities.

. Core member for the investigation of the failures on shop floor

. Carried out Review & Closing of Batch Manufacturing Records and Batch

yields at each stage.

. Functioned as a Member of Self Inspection Team

. Played an Active role to increase yield of all products manufactured

in my Module

. Carried out Review & Closing of Batch Manufacturing Records and Batch

yields at each stage.

Officer - Manufacturing September

2003 to October 2005

Cipla Ltd - Ponda, Goa

Cipla is among the top three largest pharmaceutical companies in India.

Manufacturing facilities approved by leading drug regulatory authorities

including the US-FDA, UK-MHRA, MCC, ANVISA, TGA and WHO.

(http://www.cipla.com)

As Officer-Solid Orals manufacturing

. Supervised Day-to-Day activities related to manufacturing of Tablet &

capsules - Dispensing, Granulation, Compression and coating,

Capsulation and documentation as per cGMP.

. Effectively carried out In-process control checks in order to monitor

and if necessary to adjust the process and/or to ensure that the

intermediate or finished product conforms to its specification.

. Daily Manpower and Production planning.

. Maintained shop floor Documents and cGMP records.

. Carried out Calibration of manufacturing Instruments and equipments.

. Played an active role in Rejection controls in order to improve the

Yields.

. Managed various equipment in Tablet & capsule Manufacturing such as

Sifter, Multimill, RMG, FBD, Octagonal Blender, Neocota, Compression

Machine (24, 45 & 75 Stations), Matic-90 capsulation m/c.

Education

Master of Science: Pharmaceutical Technology, 2008Vinayaka Missions

University - Salem, Tamilnadu, India

Bachelor of Science: Pharmacy, 2003 Maharashtra College of Pharmacy -

Nilanga, Maharashtra, India

Accolades

. Bagged Best Performer of the Quarter award at Dr. Reddy's Laboratories

Ltd, Hyderabad. (Played an Active

role to increase yield of all products manufactured in my Module)

. Functioned as a Member of Self Inspection Team.

. Review Article on "PROCESS VALIDATION AND IT'S IMPORTANCE IN

PHARMACEUTICAL INDUSTRY" published in the PHARMA BUZZ National

Magazine of India of Jan 2011. (Volume 6/ Issue 01, page 32 -36)

Personal Information

Sex: Male

Nationality/Race: Indian/Asian

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